Drug

Belimumab

Approved · EMA

Late-stage development

Also known as Benlysta.

RxNorm1092437UNII73B0K5S26A

Active clinical trials

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Randomized Controlled Phase I Clinical Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GNC-038 Tetra-specific Antibody Injection in Systemic Lupus Erythematosus

Clinical trial2026-07-10Results expected Q4 2027 · ClinicalTrials.gov

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

Clinical trial2026-07-09Results expected Q1 2028 · ClinicalTrials.gov

A Randomized, Double-Blind, Placebo-Controlled Study of Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

Belimumab and Rituximab Compared to Rituximab Alone for the Treatment of Primary Membranous Nephropathy (ITN080AI)

Clinical trial2026-06-24Results expected Q1 2029 · ClinicalTrials.gov

A Phase 1, First-time-in-human, Four-part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of GSK4527363 in Healthy Participants (Part A), Participants With Active Systemic Lupus Erythematosus (Part B), Healthy Participants of Chinese and Japanese Descent (Part C) and Participants With Interstitial Lung Disease Associated With Connective Tissue Disease (Part D)

Clinical trial2026-06-22Results expected Q1 2028 · ClinicalTrials.gov

Pilot Trial of Belimumab in Early Lupus

Clinical trial2026-06-12Results expected Q3 2028 · ClinicalTrials.gov

A Phase 4, Multicenter, Prospective, Open-Label Study Describing the Efficacy and Safety of Belimumab Administered Subcutaneously in Adult Participants With Early Systemic Lupus Erythematosus

Clinical trial2026-06-03Results expected Q2 2027 · ClinicalTrials.gov

A Multi-Center, Open-Label Study to Evaluate Safety, Efficacy and Pharmacokinetics of Belimumab Plus Standard Therapy in Chinese Paediatric Patients With Active Systemic Lupus Erythematosus (SLE)

Clinical trial2026-05-11Results posted · ClinicalTrials.gov

A Phase 1 Evaluation of the Safety of Belimumab in People With Idiopathic CD4 Lymphopenia and Autoantibodies (Phoebe)

Clinical trial2026-04-20Results expected Q1 2027 · ClinicalTrials.gov

A Pilot Study of Belimumab (Benlysta) for Prevention of Chronic Graft-versus-Host Disease Following Allogeneic Hematopoietic Cell Transplantation

Clinical trial2026-04-20Results posted · ClinicalTrials.gov

Drug Safety Update: Belimumab (Benlysta▼): increased risk of serious psychiatric events seen in clinical trials

Regulatory2019-04-16MHRA

Approval: Benlysta (EMA)

Regulatory2011-07-13EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Belimumab

Aliases & brands

Benlysta

RxNorm CUI

1092437

UNII

73B0K5S26A

Regulatory jurisdictions

mhraema

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2011-07-13

Latest approval

2011-07-13

Authorities

EMA · MHRA

Total events

emaEuropean Medicines Agency· 1 event

2011-07-13Approval

Approval: Benlysta (EMA)

Indication: Benlysta is indicated as add-on therapy in patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease… Show full indication

Benlysta is indicated as add-on therapy in patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti‑dsDNA and low complement) despite standard therapy. Benlysta is indicated in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis. Benlysta is indicated as add-on therapy in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti dsDNA and low complement) despite standard therapy.

Evidence ↗

mhraMedicines and Healthcare products Regulatory Agency· 1 event

2019-04-16Safety communicationSafety

Drug Safety Update: Belimumab (Benlysta▼): increased risk of serious psychiatric events seen in clinical trials

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).